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Medicines
United States
Adalimumab

FDA 2024

Adalimumab

Cyltezo

40MG/0.4ML InjectionUnited StatesMarketedAuthorised 30 Apr 2024

Open in the registerAsk Osler about it

On this page

In other countries
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

CyltezoEuropean Union · Boehringer Ingelheim International GmbHSame brand
Humira®Serbia · 40mg/0.4mL · rastvor za injekciju u napunjenom injekcionom penu · Abbvie D.O.O. BeogradSame strength and form
Amgevita Solution for Injection in Prefilled Autoinjector 40 MG/0.4 MLSingapore · 40mg/0.4mL · injection, solution · Amgen Biotechnology Singapore Pte LTDSame strength and form
AMGEVITA SOLUTION FOR INJECTION IN PREFILLED SYRINGE 20 mg/0.4 mlSingapore · 20 mg/0.4 ml · injection, solution · Amgen Biotechnology Singapore Pte LTDSame strength and form
Humira Solution for Injection 40MG/0.4ML (Pre-Filled Syringe)Singapore · 40mg/0.4ml · injection, solution · Abbvie Pte. LTD.Same strength and form

More with the same substance on this register

AbriladaAdalimumab · 10MG/0.2ML, 20MG/0.4ML, 40MG/0.8ML · injectableUnited States
AmjevitaAdalimumab · 20MG/0.4ML, 40MG/0.8ML · injectableUnited States

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Amgevita 20 MG Solucion Inyectable en Jeringa Precargada

Spain · 20 mg · solución inyectable · Amgen Europe B.V.

Same form

🇪🇸Amgevita 40 MG Solucion Inyectable en Jeringa PrecargadaSpain · 40 mg · solución inyectable · Amgen Europe B.V.Same form

🇪🇸Amgevita 40 MG Solucion Inyectable en Pluma PrecargadaSpain · 40 mg · solución inyectable · Amgen Europe B.V.Same form

🇮🇹AmgevitaItaly · Soluzione iniettabile · Amgen Europe B.V.Same form

🇮🇹HefiyaItaly · Soluzione iniettabile · Sandoz GMBHSame form

🇮🇹HukyndraItaly · Soluzione iniettabile · Stada Arzneimittel AGSame form

🇳🇱Amgevita 20 mg, oplossing voor injectie in een voorgevulde spuitNetherlands · Oplossing voor injectie · Amgen Europe B.V.Same form

🇳🇱Amgevita 20 mg, oplossing voor injectie in een voorgevulde spuitNetherlands · Oplossing voor injectie · Amgen Europe B.V.Same form

🇳🇱Amgevita 40 mg, oplossing voor injectie in een voorgevulde penNetherlands · Oplossing voor injectie · Amgen Europe B.V.Same form

🇳🇿AmgevitaNew Zealand · Inj 40 mg per 0.8 ml prefilled syringeSame form

🇳🇿AmgevitaNew Zealand · Inj 20 mg per 0.4 ml prefilled syringeSame form

🇳🇿AmgevitaNew Zealand · Inj 40 mg per 0.8 ml prefilled penSame form

🇷🇴AMGEVITA 40 mgRomania · 40mg/0.8ml · sol inj. in seringa preumpluta · Amgen Europe B.V.Same form

🇷🇴HulioRomania · 40mg · sol inj. in pen preumplut · Mylan S.A.S.Same form

🇷🇴HUMIRA 20 mgRomania · 20mg · sol inj. in seringa preumpluta · Abbvie Deutschland GMBH & Co. KGSame form

🇷🇸Hukyndra®Serbia · 80mg · rastvor za injekciju u napunjenom injekcionom špricu · Hemofarm Ad VRŠAcSame form

🇷🇸Hukyndra®Serbia · 40mg · rastvor za injekciju u napunjenom injekcionom špricu · Hemofarm Ad VRŠAcSame form

🇸🇦Hadlima 40MG/0.8ML Injection in PFPSaudi Arabia · Catalent Belgium SASame form

🇸🇦Hadlima 40MG/0.8ML Injection in Pre-Filled SyringSaudi Arabia · Catalent Belgium SASame form

🇸🇦Humira 40MG/0.4ML Pre- Filled SyringeSaudi Arabia · Vetter PharmaSame form

🇧🇷AmgevitaBrazil · Amgen Biotecnologia do Brasil Ltda.Same substance

🇧🇷AtenfeBrazil · Megalabs Farmaceutica S.A.Same substance

🇧🇷Bio-Manguinhos AdalimumabeBrazil · Fundação Oswaldo CruzSame substance

🇨🇦AbriladaCanada · 20 MG / 0.4 ML · Solution · Pfizer Canada UlcSame substance

🇨🇦HadlimaCanada · 40 MG / 0.4 ML · Solution · Samsung Bioepis Co., LTDSame substance

🇨🇦Hadlima PushtouchCanada · 40 MG / 0.4 ML · Solution · Samsung Bioepis Co., LTDSame substance

🇪🇺AmgevitaEuropean Union · Amgen Europe B.V.Same substance

🇪🇺AmsparityEuropean Union · Pfizer Europe MA EEIGSame substance

🇭🇷AmgevitaCroatiaSame substance

🇭🇷HukyndraCroatiaSame substance

🇭🇷HulioCroatiaSame substance

🇹🇼Yuflyma 40 mg solution for injectionTaiwan · 注射劑 · 台灣賽特瑞恩有限公司Same substance

Documents

The official texts, at the regulator.

Register entryFDA

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration

FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.

Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Adalimumab
Strength: 40MG/0.4ML
Dosage form: Injection
Route: Subcutaneous
Register: United States (FDA)
Status: Marketed
Status in the register: Licensed / Rx
Authorised: 30 Apr 2024
Registration: BLA 761058
Marketing authorisation holder: Boehringer Ingelheim Pharmaceuticals, Inc.
Procedure: 351(k) Interchangeable
Supply: Rx

FDA

CyltezoAdalimumab · 40MG/0.8ML · injectable🇺🇸United States

FDAHadlimaAdalimumab · 40MG/0.8ML · injectable🇺🇸United States

FDAHulioAdalimumab · 20MG · injectable🇺🇸United States

FDAHumiraAdalimumab · 40MG/0.8ML · syringe🇺🇸United States

FDAHumiraAdalimumab · 40MG/0.8ML · vial🇺🇸United States

FDAHyrimozAdalimumab · 40MG/0.8ML · injectable🇺🇸United States

FDAIdacioAdalimumab · 40MG/0.8ML · injectable🇺🇸United States

FDASimlandiAdalimumab · 40MG/0.4ML · injectable🇺🇸United States

FDAYuflymaAdalimumab · 40MG/0.4ML · injectable🇺🇸United States

FDAYusimryAdalimumab · 40MG · injectable🇺🇸United States